Version July 2025
Diffuse large B-cell lymphoma, relapsed or refractory: IV:
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Cyclea |
Dosing schedule |
|---|---|
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aEach treatment cycle is 28 days. bDosing is based on actual body weight. | |
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Cycle 1 |
12 mg/kgb on days 1, 4, 8, 15, and 22 (in combination with lenalidomide) |
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Cycles 2 and 3 |
12 mg/kgb on days 1, 8, 15, and 22 (in combination with lenalidomide) |
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Cycle 4 and beyond |
12 mg/kgb on days 1 and 15 every 28 days (in combination with lenalidomide) |
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Administer tafasitamab in combination with lenalidomide for a maximum of 12 cycles, followed by tafasitamab monotherapy until disease progression or unacceptable toxicity. | |
Administer in a facility with immediate access to emergency equipment and appropriate medical support to manage infusion reactions.
Premedication: Administer premedication (may include acetaminophen, an H1 receptor antagonist, an H2 receptor antagonist, and/or glucocorticoids) 30 minutes to 2 hours prior to infusion to minimize infusion reaction. If no infusion reaction during the initial 3 infusions, premedication is optional for subsequent infusions. If an infusion reaction occurs, administer premedication(s) prior to each subsequent infusion.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Note: Renal function may be estimated using the Cockcroft-Gault equation.
CrCl 30 to 89 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling; however, CrCl 30 to 89 mL/minute had no clinically meaningful difference on tafasitamab pharmacokinetics.
CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
End stage renal disease: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Mild impairment (total bilirubin ≤ ULN and AST > ULN, or total bilirubin 1 to 1.5 times ULN and any AST): There are no dosage adjustments provided in the manufacturer's labeling; however, mild impairment had no clinically meaningful difference on tafasitamab pharmacokinetics.
Moderate or severe impairment (total bilirubin >1.5 times ULN and any AST): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m2 : The dosing in the FDA-approved prescribing information should be followed in all patients, regardless of obesity status. If a patient with a BMI ≥30 kg/m2 experiences high-grade toxicity from systemic anticancer therapy, the same dosage modification recommendations should be followed for all patients, regardless of obesity status (Ref). Note: Dosing is based on actual body weight (per the prescribing information).
|
Adverse reaction |
Severity |
Dosage modification |
|---|---|---|
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Hematologic toxicity |
Platelets ≤50,000/mm3 |
Withhold tafasitamab (and lenalidomide) and monitor CBC weekly until platelet count is ≥50,000/mm3, then resume tafasitamab at the same dose (and lenalidomide at a reduced dose; refer to Lenalidomide monograph). |
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Neutrophil count ≤1,000/mm3 for at least 7 days or neutrophil count ≤1,000/mm3 with body temperature increase to ≥100.4°F (≥38°C) or neutrophil count <500/mm3 |
Withhold tafasitamab (and lenalidomide) and monitor CBC weekly until neutrophil count is ≥1,000/mm3, then resume tafasitamab at the same dose (and lenalidomide at a reduced dose; refer to Lenalidomide monograph). | |
|
Infusion-related reaction |
Grade 2 (moderate) |
Interrupt infusion immediately and manage signs/symptoms. Once signs/symptoms resolve or reduce to grade 1, resume infusion at no more than 50% of the rate at which the reaction occurred. If no further reaction within 1 hour and vital signs are stable, may increase infusion rate every 30 minutes as tolerated to rate at which the reaction occurred. |
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Grade 3 (severe) |
Interrupt infusion immediately and manage signs/symptoms. Once signs/symptoms resolve or reduce to grade 1, resume infusion at no more than 25% of the rate at which the reaction occurred. If no further reaction within 1 hour and vital signs are stable, may increase infusion rate every 30 minutes as tolerated to a maximum of 50% of the rate at which the reaction occurred. Stop infusion immediately if reaction returns upon rechallenge. | |
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Grade 4 (life threatening) |
Stop infusion immediately and permanently discontinue tafasitamab. |
Refer to adult dosing.
Tafasitamab may cause severe hematologic toxicity, including neutropenia, thrombocytopenia, and anemia. Grade 3 or 4 neutropenia, including febrile neutropenia, is common. Treatment interruption and/or dosage modification for hematologic toxicity may be warranted depending on severity.
Tafasitamab commonly causes infection, including serious infection (grade 3 or higher). Opportunistic infection may also occur. In the clinical study, frequently observed infections included respiratory tract infection, urinary tract infection, bronchitis, nasopharyngitis, and pneumonia. The most frequently reported grade 3 infection was pneumonia.
Onset: Varied; infections may occur at any time during therapy and following the last dose.
Tafasitamab may cause an infusion related reaction. Signs and symptoms include chills, fever, flushing, dyspnea, skin rash, and hypertension. Based on severity, interrupting the infusion or discontinuation may be warranted.
Onset: Rapid; the majority of patients experienced infusion related reactions during cycle 1 or 2.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Cardiovascular: Peripheral edema (24%)
Dermatologic: Skin rash (15%)
Endocrine & metabolic: Decreased serum albumin (26%), decreased serum calcium (47%), decreased serum magnesium (22%), decreased serum phosphate (20%), hypokalemia (19%), increased gamma-glutamyl transferase (34%), increased serum glucose (49%), increased uric acid (20%)
Gastrointestinal: Abdominal pain (15%), constipation (17%), decreased appetite (22%), diarrhea (36%), nausea (15%), vomiting (15%)
Genitourinary: Urinary tract infection (17%)
Hematologic & oncologic: Anemia (36%; grade 3: 7%), febrile neutropenia (12%; grades 3/4: 12%), neutropenia (51%; grade 3: 25%; grade 4: 25%), prolonged partial thromboplastin time (46%; grade 3/4: 4%), thrombocytopenia (31%; grade 3: 12%; grade 4: 6%)
Hepatic: Increased serum aspartate aminotransferase (20%)
Infection: Infection (73%, including opportunistic infection; serious infection: 26%)
Nervous system: Fatigue (≤38%)
Neuromuscular & skeletal: Asthenia (≤38%), back pain (19%), muscle spasm (15%)
Renal: Increased serum creatinine (20%)
Respiratory: Bronchitis (16%), cough (26%), dyspnea (12%), respiratory tract infection (24%)
Miscellaneous: Fever (24%)
1% to 10%:
Dermatologic: Alopecia (3%), erythema of skin (5%), hyperhidrosis (3%), pruritus (10%)
Endocrine & metabolic: Weight loss (5%)
Gastrointestinal: Dysgeusia (6%)
Hematologic & oncologic: Basal cell carcinoma of skin (1%), lymphocytopenia (6%)
Infection: Sepsis (5%)
Nervous system: Headache (9%), paresthesia (7%)
Neuromuscular & skeletal: Arthralgia (9%), limb pain (9%), musculoskeletal pain (3%)
Respiratory: Exacerbation of chronic obstructive pulmonary disease (1%), nasal congestion (5%), nasopharyngitis (10%), pneumonia (10%)
Miscellaneous: Infusion related reaction (6%)
There are no contraindications listed in the manufacturer's US labeling.
Canadian labeling: Hypersensitivity to tafasitamab or any component of the formulation.
Special populations:
• Older adult: Patients ≥65 years of age experienced more serious adverse reactions compared to younger patients.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous [preservative free]:
Monjuvi: Tafasitamab-cxix 200 mg (1 ea)
No
Solution (reconstituted) (Monjuvi Intravenous)
200 mg (per each): $1,675.04
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous:
Minjuvi: Tafasitamab-cxix 200 mg (1 ea)
Tafasitamab is available through specialty distributors. Information regarding distribution is available from the manufacturer at https://www.monjuvihcp.com/resources.
IV: Infuse initial infusion at a rate of 70 mL/hour for the first 30 minutes, then increase the rate so that the infusion is administered within 1.5 to 2.5 hours. Infuse subsequent infusions over 1.5 to 2 hours. Infuse entire contents of bag. Do not administer other medications through the same infusion line. No incompatibilities have been observed between tafasitamab and infusion sets made of polyurethane (PUR) or PVC.
Administer in a facility with immediate access to emergency equipment and appropriate medical support to manage infusion reactions. Premedications are recommended to minimize infusion reaction. Monitor for infusion reactions.
Diffuse large B-cell lymphoma, relapsed or refractory: Treatment (in combination with lenalidomide) of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified in adults, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.
Tafasitamab may be confused with fostamatinib, trastuzumab.
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor
Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid
BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid
Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor
Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid
Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor
Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Miscellaneous Oncologic Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor
COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Denosumab: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification
Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid
Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification
Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification
Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Mumps- Rubella- or Varicella-Containing Live Vaccines may increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor
Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor
Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor
Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification
Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification
Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification
Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification
Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor
Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid
Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid
Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid
Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid
Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor
Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid
Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification
Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Zoster Vaccine (Live/Attenuated): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
Females of reproductive potential should use effective contraception during therapy and for at least 3 months after the last tafasitamab dose.
Tafasitamab is initially used in combination with lenalidomide for relapsed or refractory diffuse large B-cell lymphoma. Refer to the Lenalidomide monograph for additional information related to pregnancy testing, male and female contraception, and fertility. In the clinical study, when tafasitamab was continued as monotherapy, urine pregnancy testing was conducted prior to each tafasitamab infusion (Salles 2020).
Tafasitamab is a humanized monoclonal antibody (IgG1/2 hybrid). Placental transfer of human IgG is dependent upon the IgG subclass, maternal serum concentrations, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).
Based on the mechanism of action, tafasitamab may cause depletion of fetal CD-19 positive immune cells. The administration of live vaccines should be deferred for neonates and infants exposed to tafasitamab in utero until a hematology evaluation can be completed.
Tafasitamab is initially used in combination with lenalidomide, which is contraindicated in pregnancy. Refer to the Lenalidomide monograph for additional information.
It is not known if tafasitamab is present in breast milk.
Tafasitamab is a monoclonal antibody (IgG1/2 hybrid); maternal IgG can be detected in breast milk. Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during tafasitamab treatment and for at least 3 months after the last tafasitamab dose.
Tafasitamab is used in combination with lenalidomide. Refer to the Lenalidomide monograph for additional information.
Monitor CBC prior to each treatment cycle and throughout treatment. Evaluate pregnancy status prior to treatment initiation (in females of reproductive potential). Monitor for signs/symptoms of infection, infusion reactions.
The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.
Tafasitamab is a humanized CD19-directed, Fc-modified monoclonal antibody that binds to CD19 antigen, which is expressed on the surface of pre-B and mature B lymphocytes and on several B-cell malignancies, including diffuse large B-cell lymphoma. After binding to CD19, tafasitamab mediates B-cell lysis through apoptosis and immune effector mechanisms, including antibody-dependent cellular cytotoxicity and phagocytosis. Administering in combination with lenalidomide results in increased antibody-dependent cellular cytotoxicity activity compared to either agent alone.
Onset: Peripheral B-cell counts were reduced by 97% after 8 days and by 100% at the nadir (reached within 16 weeks of treatment).
Distribution: Vd: 9.3 L.
Half-life elimination: 17 days.
Excretion: Clearance: 0.41 L/day.
Body weight: Body weight (40 to 163 kg) has a significant effect on tafasitamab pharmacokinetics, with higher clearance and Vd expected with higher body weight.
